Details for New Drug Application (NDA): 021560

✉ Email this page to a colleague

NDA 021560 describes ZORTRESS, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. Additional details are available on the ZORTRESS profile page.

The generic ingredient in ZORTRESS is everolimus. There are twelve drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the everolimus profile page.

Summary for 021560

Tradename:	ZORTRESS
Applicant:	Novartis
Ingredient:	everolimus
Patents:	0

Pharmacology for NDA: 021560

Mechanism of Action	Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inhibitors Protein Kinase Inhibitors mTOR Inhibitors
Physiological Effect	Decreased Immunologic Activity

Medical Subject Heading (MeSH) Categories for 021560

Antineoplastic Agents
Immunosuppressive Agents

Suppliers and Packaging for NDA: 021560

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZORTRESS	everolimus	TABLET;ORAL	021560	NDA	Novartis Pharmaceuticals Corporation	0078-0414	0078-0414-20	60 BLISTER PACK in 1 BOX (0078-0414-20) / 1 TABLET in 1 BLISTER PACK (0078-0414-61)
ZORTRESS	everolimus	TABLET;ORAL	021560	NDA	Novartis Pharmaceuticals Corporation	0078-0415	0078-0415-20	60 BLISTER PACK in 1 BOX (0078-0415-20) / 1 TABLET in 1 BLISTER PACK (0078-0415-61)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.25MG
Approval Date:	Apr 20, 2010	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.5MG
Approval Date:	Apr 20, 2010	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.75MG
Approval Date:	Apr 20, 2010	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021560

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	ZORTRESS	everolimus	TABLET;ORAL	021560-003	Apr 20, 2010	⤷ Sign Up	⤷ Sign Up
Novartis	ZORTRESS	everolimus	TABLET;ORAL	021560-003	Apr 20, 2010	⤷ Sign Up	⤷ Sign Up
Novartis	ZORTRESS	everolimus	TABLET;ORAL	021560-001	Apr 20, 2010	⤷ Sign Up	⤷ Sign Up
Novartis	ZORTRESS	everolimus	TABLET;ORAL	021560-001	Apr 20, 2010	⤷ Sign Up	⤷ Sign Up
Novartis	ZORTRESS	everolimus	TABLET;ORAL	021560-001	Apr 20, 2010	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.